Ignite Creation Date:
2024-05-06 @ 9:40 AM
Last Modification Date:
2024-10-26 @ 12:18 PM
Study NCT ID:
NCT03049631
Status:
COMPLETED
Last Update Posted:
2020-07-14
First Post:
2017-02-08
Brief Title:
Red Raspberry Polyphenols on Gut Microbiome
Sponsor:
Clinical Nutrition Research Center Illinois Institute of Technology
Organization:
Clinical Nutrition Research Center Illinois Institute of Technology
Study Overview
Official Title:
The Reciprocal Interactions Between Red Raspberry Polyphenols and Gut Microbiome Composition Affect Insulin Sensitivity
Status:
COMPLETED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RRB2
Brief Summary:
The primary objective aims are to assess the effects of regular consumption of red raspberries RRB with and without fructooligosaccharide FOS on the composition of the gut microbiota after 4 week intake and in parallel characterize plasma and urine metabolite profiles examining qualitative and quantitative intervention associated changes
Detailed Description:
The study will be performed as a single-blinded randomized crossover manner Thirty subjects 20 insulin resistant subjects and 10 healthy subjects will be randomly assigned into one of two sequences sequence A n15 will be RRB then RRBFOS which means subject will consume only RRB 125 gdayd equivalent to 1 cup fresh RRB with breakfast for 4 weeks and then after a 4-week washout period that subject will consume the RRB with FOS 125 gd RRB and 8 gd FOS for 4 weeks sequence B n15 will be RRBFOS then RRB which means subject will receive the RRB with FOS for 4 weeks a 4-week washout and then the RRB for another 4-week At the beginning and end of each 4-week treatment subjects will undergo a 6-h Study Day 4 study days in 12-week study duration followed by a 1-h next morning follow-up visit
Subjects will be required to meet several inclusion and exclusion criteria which will be assessed through online survey and on-site clinic assessments including questionnaires blood analysis and anthropometric measures Eligible subjects will be invited to participate in the study Each subject will be asked to come for 1 Screening Visit 4 dinner pick-ups the day before each Study Day 4 Study Days and 6 Weekly Meetings
During the Screening Visit subjects will read sign and date a written Institutional Review Board approved Informed Consent Form prior to performing any study procedure And then they will be assessed their qualification instructed on the process for completing study questionnaires and counseled to restrict intake of colored plant foods rich in phytonutrients the 3 days prior to each Study Day They will be asked to restrict alcohol intake coffeetea caffeinated beverage intake and moderate vigorous physical activity and to drink plenty of water to maintain hydration in the 24 h prior to each Study Day They will be instructed to come to the Clinical Nutrition Research Center CNRC the day before each Study Day to pick up their dinner meal and evening snack Subjects will be asked to get at least 7 hours sleep and to come to the CNRC after a 10-h overnight fasting on each Study Day
Each Study Day will require subjects to be in the clinic for 7 h to complete all baseline and post challenge beverage testing procedures including a 6 h study day and a 1 h next morning follow-up visit Subjects will be evaluated for compliance with the protocol diet exercise sleep fasting have their body weight and blood pressure measured ingest a cup of red raspberry drink 250 g RRB equivalent to 2 cups fresh RRB and 64 g glucose and their blood urine and feces samples will be collected
Subjects will be required to meet several inclusion and exclusion criteria which will be assessed through online survey and on-site clinic assessments including questionnaires blood analysis and anthropometric measures Eligible subjects will be invited to participate in the study Each subject will be asked to come for 1 Screening Visit 4 dinner pick-ups the day before each Study Day 4 Study Days and 6 Weekly Meetings
During the Screening Visit subjects will read sign and date a written Institutional Review Board approved Informed Consent Form prior to performing any study procedure And then they will be assessed their qualification instructed on the process for completing study questionnaires and counseled to restrict intake of colored plant foods rich in phytonutrients the 3 days prior to each Study Day They will be asked to restrict alcohol intake coffeetea caffeinated beverage intake and moderate vigorous physical activity and to drink plenty of water to maintain hydration in the 24 h prior to each Study Day They will be instructed to come to the Clinical Nutrition Research Center CNRC the day before each Study Day to pick up their dinner meal and evening snack Subjects will be asked to get at least 7 hours sleep and to come to the CNRC after a 10-h overnight fasting on each Study Day
Each Study Day will require subjects to be in the clinic for 7 h to complete all baseline and post challenge beverage testing procedures including a 6 h study day and a 1 h next morning follow-up visit Subjects will be evaluated for compliance with the protocol diet exercise sleep fasting have their body weight and blood pressure measured ingest a cup of red raspberry drink 250 g RRB equivalent to 2 cups fresh RRB and 64 g glucose and their blood urine and feces samples will be collected
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None